F.D.R.H. received no funding for this work. Bayer AG and Johnson & Johnson Pharmaceutical Research & Development, LLC, through funding of the professional medical writing services provided by IL. The sponsors were not involved in writing or editing the material. The authors take full responsibility for all content…F.D.R.H. has received occasional speaker fees or sponsorship from a variety of pharmaceutical companies, some with interests in AF including Boehringer Ingelheim, Pfizer, and Bayer. I.L. is an employee of Chameleon Communications International which received funding from the sponsors for her time on this manuscript.

Bayer, who funded the editorial assistance, make Rivaroxaban, one of the drugs discussed in the article. Many of the companies from which Prof Hobbs has received money also make new oral anticoagulants. Chameleon Communications has been involved in preparing several other manuscripts in other journals on new anticoagulants over recent months.

The second, by Prof Joerg Kreuzer, was that edition’s “Editor’s Choice” article. Prof Kreuzer’s funding and conflict of interest statement read as follows.

This work was supported by Boehringer Ingelheim. The author was fully responsible for all content and editorial decisions. The author received no financial support or other compensation related to the development of the paper. Editorial support was funded by Boehringer Ingelheim…Conflict of interest: None declared…The authors would like to thank Rebecca Gardner of PAREXEL, UK, for editorial assistance in the preparation of this article.

Boehringer Ingelheim, make Dabigatran etexilate, a drug promoted in the article’s conclusion.

Concerned about these clear conflicts of interests, I wrote a letter to QJM arguing that the involvement of industry in the funding of review articles generates bias, probably above and beyond the mere choice of topics on which they focus. I requested answers to these four questions:

a) What is Isabelle Leach’s expertise in this field?

b) Could Chameleon Communications or PAREXEL highlight any published work with which they had assisted that recommends not prescribing a drug manufactured by the sponsor of the work?

c) Would the sponsors, PAREXEL or Chameleon Communications be willing to make public the agreements or contracts between their organizations pertaining to these QJM papers? and

d) Whether the editors had attempted to source an independent review on this topic and, if not, why not?

I concluded –

How long are we going to put up with a situation where our practice is informed by biased evidence summarized for us by people who have financial relationships with companies set to profit from alterations to our practice? These flagrant conflicts of interest would not be tolerated in other industries. We need to get our house in order.

Both claimed that conflict of interest was a “complex” area and defended their conduct by claiming all conflicts of interests had been declared and that the articles had been through peer review – claims I had not disputed. None of my questions were answered.

Prof Hobbs noted “Dr Yates…does not state what material he considers inaccurate or imbalanced” and asked “Surely Dr Yates does not think that the paper should not have mentioned the emerging evidence base for these novel agents in addition to reviewing the data and associated usage of warfarin and aspirin?” He asserted “The paper underwent independent review by the Journal and the authors responded to feedback. If the paper had not been assessed as a balanced review it would not have been accepted for publication.”

The editor, Prof Michael Bannon, declined to print my response to Prof Hobbs letter stating “The editorial decision is that this issue is now closed and no further correspondence will be considered regarding this.”

Happily, the internet offers me the opportunity to conclude a debate I believe to have been prematurely closed. This is the letter I submitted to QJM –

I thank the editors and Prof Hobbs for taking the time to respond to my letter on industry supported review articles [1, 2] but note the questions I raised in my letter are yet to be answered.

Both the editors [1] and Prof Hobbs [2] state the peer review process and the declaration of conflicts of interest as factors that protect readers from any bias. I am aware of no body of research that supports this position.

Research on the impact of disclosure of conflict of interest is contradictory [3, 4]. Recent work highlighting systematic differences between industry funded and independent review and comment articles on the rosiglitazone controversy suggest peer review offers no defence against funder bias finding its way into peer reviewed literature [5].

In answer to Prof Hobbs’ question [2], I believe it is important that clinicans are able to access review articles on this topic. However, they should be written by authors who have no financial relationship with the companies who make the products under discussion.

I am no expert on anticoagulation so am unable to critique his paper. Most other readers will be in the same position and thus unable to tell whether his clear conflicts of interest have affected the way in which he has presented the evidence. For this reason, journals should not be publishing reviews by authors with clear conflicts of interest and clinicians should not allow such articles to influence their practice.

Amy Wang’s review of articles commenting on the Rosiglitazone controversy, is well worth a read. After reading it, it is difficult to argue peer review offers any defence against bias creeping into the literature.

Disclosure is necessary, but not sufficient, when it comes to ethical medical writing assistance

As professional medical writers (NOT ghostwriters!) we read the guest post from Mr Tom Yates with much interest. We believe that disclosure of medical writing assistance, whether funded from non-commercial or commercial sources, is necessary, but not sufficient, when it comes to ethical medical writing assistance. The practices that professional medical writers follow involve far more than just disclosure!

In this regard, the freely available “anti-ghostwriting” checklist1 may be of particular interest to Mr Yates and your readers. When authors sign and submit this checklist, they agree that the writer(s) they used can, if requested by a journal editor, “provide evidence that the manuscript was prepared in accordance with international guidelines for ethical medical writing (e.g., Uniform Requirements for Manuscripts Submitted to Biomedical Journals… Good Publication Practice for Pharmaceutical Companies… Position Statements from the European or American Medical Writers Associations or the International Society for Medical Publication Professionals).”

The World Association of Medical Editors states that ‘‘editors should make clear in their journal’s information for authors that medical writers can be legitimate contributors.’’ Evidence is now showing that medical writers are legitimate AND valuable contributors. Manuscripts prepared with professional medical writing assistance are rarely retracted for misconduct,2 are more compliant with CONSORT guidelines3 and are accepted more quickly for publication.4

Mr Yates raises particular concerns about review articles. As professional medical writers, we assist authors with the often long and laborious effort required to write a review that complies with best practice reporting guidelines (eg, PRISMA). The authors we assist are experts in their field and may receive industry support. We help ensure that financial conflicts of interest are disclosed in a complete and transparent manner. Mr Yates’ proposed solution of banning review articles authored by those with ANY financial conflicts of interest has been tried…and it failed. Indeed, the highly respected New England Journal of Medicine had to change this “blanket ban” policy.5 The editors explained that “…our ability to provide comprehensive, up-to-date information, especially on recent advances in therapeutics, has been constrained. The current policy states that “…because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any significant [our emphasis] financial interest in a company (or its competitor) that makes a product discussed in the article.

If we want clinicians to have access to timely and high-quality publications from commercial or non-commercial research, then professional medical writers are part of the solution, not the problem.

Disclosures: All GAPP members have or do hold leadership roles at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organizations. GAPP members have or do provide professional medical writing services to not-for-profit and for-profit clients.